Compositions of tolperisone

Abstract

The present disclosure relates to tolperisone, or a pharmaceutically acceptable salt or hydrate thereof, with 10 ppm 2-methyl-1-(4-methylphenyl)-propenone (4-MMPPO) or less, methods of producing the same, as well as compositions related thereto. The disclosure further relates to methods of treating a subject with tolperisone under conditions that limit exposure of the subject to tolerable levels of 4-MMPPO.

What is claimed is: 
     
       1. Tolperisone, or a pharmaceutically acceptable salt or hydrate thereof, with 10 ppm 2-methyl-1-(4-methylphenyl)-propenone (4-MMPPO) or less. 
     
     
       2. The tolperisone, or pharmaceutically acceptable salt or hydrate thereof, according to  claim 1 , with 9 ppm 4-MMPPO or less. 
     
     
       3. The tolperisone, or pharmaceutically acceptable salt or hydrate thereof, according to  claim 1 , with 8 ppm 4-MMPPO or less. 
     
     
       4. The tolperisone, or pharmaceutically acceptable salt or hydrate thereof, according to  claim 1  with 7 ppm 4-MMPPO or less. 
     
     
       5. The tolperisone, or pharmaceutically acceptable salt or hydrate thereof, according to  claim 1 , with 6 ppm 4-MMPPO or less. 
     
     
       6. The tolperisone, or pharmaceutically acceptable salt or hydrate thereof, according to  claim 1 , wherein the pharmaceutically acceptable salt of tolperisone comprises tolperisone hydrochloride. 
     
     
       7. The tolperisone, or pharmaceutically acceptable salt or hydrate thereof, according to  claim 2 , wherein the pharmaceutically acceptable salt of tolperisone comprises tolperisone hydrochloride. 
     
     
       8. The tolperisone, or pharmaceutically acceptable salt or hydrate thereof, according to  claim 3 , wherein the pharmaceutically acceptable salt of tolperisone comprises tolperisone hydrochloride. 
     
     
       9. The tolperisone, or pharmaceutically acceptable salt or hydrate thereof, according to  claim 4 , wherein the pharmaceutically acceptable salt of tolperisone comprises tolperisone hydrochloride. 
     
     
       10. The tolperisone, or pharmaceutically acceptable salt or hydrate thereof, according to  claim 5 , wherein the pharmaceutically acceptable salt of tolperisone comprises tolperisone hydrochloride. 
     
     
       11. A pharmaceutical composition, comprising:
 a) tolperisone, or a pharmaceutically acceptable salt or hydrate thereof; and 
 b) one or more pharmaceutically acceptable excipients,
 wherein the composition comprises less than about 10 ppm 2-methyl-1-(4-methylphenyl)-propenone (4-MMPPO). 
 
 
     
     
       12. The pharmaceutical composition of  claim 11 , comprising less than about 9 ppm 4-MMPPO. 
     
     
       13. The pharmaceutical composition of  claim 11 , comprising less than about 8 ppm 4-MMPPO. 
     
     
       14. The pharmaceutical composition of  claim 11 , comprising less than about 7 ppm 4-MMPPO. 
     
     
       15. The pharmaceutical composition of  claim 11 , comprising less than about 6 ppm 4-MMPPO. 
     
     
       16. The pharmaceutical composition of  claim 11 , wherein the pharmaceutically acceptable salt of tolperisone comprises tolperisone hydrochloride. 
     
     
       17. The pharmaceutical composition of  claim 12 , wherein the pharmaceutically acceptable salt of tolperisone comprises tolperisone hydrochloride. 
     
     
       18. The pharmaceutical composition of  claim 13 , wherein the pharmaceutically acceptable salt of tolperisone comprises tolperisone hydrochloride. 
     
     
       19. The pharmaceutical composition of  claim 14 , wherein the pharmaceutically acceptable salt of tolperisone comprises tolperisone hydrochloride. 
     
     
       20. The pharmaceutical composition of  claim 15 , wherein the pharmaceutically acceptable salt of tolperisone comprises tolperisone hydrochloride.